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Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00795288
First received: November 20, 2008
Last updated: May 27, 2014
Last verified: May 2014

November 20, 2008
May 27, 2014
August 2008
February 2013   (final data collection date for primary outcome measure)
  • Resting cerebral blood flow during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]
  • Cerebral autoregulation during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00795288 on ClinicalTrials.gov Archive Site
Impact of statin on oxygen extraction fraction and cerebral metabolism during peak period of vasospasm risk [ Time Frame: 7-10 days after hemorrhage ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subarachnoid Hemorrhage
  • Drug: Simvastatin, 80 mg/day for 21 days
    Active treatment group
  • Drug: placebo
    Control group
  • Experimental: 1
    Simvastatin, 80 mg/day
    Intervention: Drug: Simvastatin, 80 mg/day for 21 days
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • SAH from ruptured cerebral aneurysm within 48 hours of admission.
  • Modified Fisher grade 2,3,or 4
  • Planned surgical or endovascular aneurysm repair

Exclusion Criteria:

  • Pregnancy
  • SAH secondary to traumatic or mycotic aneurysms
  • Pre-ictal statin therapy
  • Contraindication to stain therapy
  • WFNS grade 5
  • Contraindications to MAP elevation on day 7-10
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795288
3857 - 54118B, 1P50NS05597701A2
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Michael Diringer, MD Washington University School of Medicine
Washington University School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP